Functional Safety Certification for Pharmacy Automation Robots: ISO 12100 Explained

Date: 2027-06-11
Location: Online
Host: Zach L

About this event

A Gap Analysis Workshop for Maintenance Technicians pursuing functional safety certification. A live 30-minute gap analysis workshop on ISO 12100 (Risk Assessment and Risk Reduction) for pharmacy automation robots, built for maintenance technicians pursuing functional safety certification. What We'll Cover: What ISO 12100 (Risk Assessment and Risk Reduction) requires and how its scope applies to pharmacy automation robots Mapping ISO 12100 clauses to the certification evidence assessors expect System-specific hazards and safety functions typical of pharmacy automation robots Common findings that delay certification, and how to avoid them A practical readiness roadmap for maintenance technicians preparing for assessment Related topics: ISO 12100 · Pharmacy Automation Robots · functional saf

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About ISO 12100 (Risk Assessment and Risk Reduction)

This hands-on workshop builds applied knowledge and team exercises around the certification requirements of ISO 12100.

EN ISO 12100 is the machinery-safety type-A standard defining the principles of risk assessment and risk reduction: it establishes the terminology, the assessment workflow, and the three-step method that every machine design and CE technical file builds on.

What it regulates

Determination of machine limits, systematic hazard identification across all lifecycle phases, risk estimation and evaluation, and iterative risk reduction: inherently safe design first, safeguarding second, information for use last.

Who must comply

Every machinery manufacturer and integrator in scope of the EU Machinery Regulation, plus modifiers of machinery in service; it is the presumption-of-conformity backbone for machinery risk assessment worldwide.

Key requirements of ISO 12100

Machine limits: use, space, time, and reasonably foreseeable misuse

Hazard identification catalogues: mechanical, electrical, thermal, noise, ergonomic, and more

Risk elements: severity of harm and probability (exposure, occurrence, avoidability)

Three-step method and verification that measures do not introduce new hazards

Documentation requirements for the risk assessment

Key concepts: ISO 12100

Type A/B/C standards

The machinery standard hierarchy — 12100 (A) principles, B-standards for aspects (13849, 13855), C-standards for machine types, C prevailing where specific.

Reasonably foreseeable misuse

Uses beyond intended operation that are predictable from human behavior and must be assessed.

Residual risk

Risk remaining after all measures, which must be communicated in the instruction handbook.

Task-hazard pair

Risk assessed per combination of task (operation, maintenance, cleaning) and hazard exposure.

Three-step method

The mandatory hierarchy: eliminate or reduce risk by design, apply safeguarding and complementary measures, then warn and instruct for residual risk.

Frequently asked questions: ISO 12100

How does ISO 12100 connect to ISO 13849?

Where step two of risk reduction relies on a control system (interlocks, light curtains, safe speed), ISO 12100's risk analysis determines the required performance of that safety function, which ISO 13849-1 formalizes as a Performance Level via its risk graph.

Is ISO 12100 mandatory for CE marking?

The Machinery Regulation mandates a risk assessment; applying EN ISO 12100 is the harmonized route that grants presumption of conformity for the assessment methodology, so in practice it is the expected baseline of every technical file.

How often must a risk assessment be revisited?

Whenever the machine, its use, or knowledge about it changes — modifications, incidents, new standards — and as part of revalidation practices; the assessment is a living document across the machine lifecycle.